Spine protection device

ABSTRACT

A surgical kit includes a shield for covering a portion of the spine of a subject. The shield can include an attachment portion adapted to engage a bone fixation assembly which is adapted to be fixed on multiple vertebra bones of the subject. The bone fixation assembly can include a vertebra joining member secured between two bone anchors. Each bone anchor can include a fastener portion adapted to be implanted into a vertebra bone and a head coupling portion adapted to secure the vertebra joining member. The shield can be coupled to the bone fixation assembly via separate coupling elements, such as a clip or an adjustable link secured between two vertebra joining members of the bone fixation assembly. Alternatively, the shield can include an integral attachment portion configured to engage the bone fixation assembly directly.

PRIORITY

This application is a continuation application of U.S. patentapplication Ser. No. 15/523,613, which is a U.S. National PhaseApplication under 35 U.S.C. § 371 of International Patent ApplicationNo. PCT/IB2016/001576, filed Oct. 3, 2016, which claims the benefit ofU.S. Provisional Application Nos. 62/235,667 (filed Oct. 1, 2015) and62/364,621 (filed Jul. 20, 2016).

The references cited in this specification, and their references, areincorporated by reference herein in their entirety where appropriate forteachings of additional or alternative details, features, and/ortechnical background.

FIELD OF THE INVENTION

This invention relates to spinal implant. More particularly, theinvention relates to a spinal device for protection of a person's spineafter laminectomy.

BACKGROUND

A laminectomy is a surgical procedure that removes a portion of thevertebral bone called the lamina—the back part of the vertebra thatcovers a person's spinal canal. Also known as decompression surgery,laminectomy enlarges the spinal canal to relieve pressure on the spinalcord or nerves (the pressure is most commonly caused by bony overgrowthswithin the spinal canal, which can occur in people who have arthritis intheir spines).

There are several unfortunate consequences of laminectomies performedworldwide that have not yet been addressed. First, the laminectomyremoves the protective posterior element of the spine. As a result, thepatient is left with only closed paraspinal muscle, fascia,subcutaneous, tissue, and skin closure. Although the lamina is notconsidered an essential supportive component of the spine, loss of thelamina results in the theoretical possibility of direct injury tonervous tissue in the operated area. In the lumbar spine, there is oftenenough protection from the muscle and fascia; however, in the cervicalspine this paraspinal musculature is limited. Secondly, scar tissuesets-in after a laminectomy, as the paraspinal muscles closed over thedura forms a fibrotic layer over it. Scar tissue surrounding the duraand nerve roots can compress the nerve roots and cauda equine, producingneural complications such as persistent, low back pain, sciatica, and/orbowel and bladder dysfunction. Third, revision surgery may provenecessary due to recurrent disk herniation, post-operative spinalstenosis (iatrogenic or acquired), or because of exuberant epiduralfibrosis. As a result, repeat exposure requires going through theprevious operative site without the help of normal landmarks andprotection of the pre-existing lamina. In such cases, there is a greaterchance of the surgeon injuring the dura, resulting in a cerebrospinal(CSF) leak. Cosmetically, as the wound contracts, the patient is leftwith a distinct contracture dimple or cavity that is often seen over thesurgical site. This “dimple” is often cosmetically undesirable,particularly in thin patients, especially over the cervical or thoracicspine.

U.S. Pat. No. 6,454,767 discloses a spinal protection device or kit forreducing formation of post-operative adhesions. The device includes afenestrated shield adapted to cover a bony dissection in the spine of avertebrate. The shield can include an elongate cavity and can includeattachment ports proximate to an edge of the shield to accept attachmentpins, as well as a plurality of attachment pins for attaching the shieldto bone. FIG. 1A is an illustration of a laminectomy of the fifth lumbarvertebrae according to U.S. Pat. No. 6,454,767. The spinal cord 24 issurrounded by a vertebral column composed of individual lumbar vertebrae26, each composed of a transverse process 30 and a spinous process 32,and lamina 40. One of the vertebrae has been subjected to laminectomy(the cut cross section is shown in hatched lines). FIG. 1B is anillustration of a shield 10 installed on the lumbar vertebrae, whereshield 10 is positioned over the laminectomy site. The attachment flats18 are attached to the spinal processes, and a set of four attachmentpins 20 are used to anchor the four corners of the shield 10 in place tothe surrounding vertebrae tissue.

There is a need for an improved spine protection device that has thefollowing desirable properties:

-   -   1) Provides protection of the spinal cord or associated nerve        roots after a laminectomy.    -   2) Prevents postoperative scarring from healing fibroblasts on        top of the dura.    -   3) Provides easy landmark so that the surgeon does not get into        the dura and causes a CSF leak during exposure for redo surgery.    -   4) Prevents cosmetic defects after laminectomy.    -   5) Easy to apply after a laminectomy or posterior spinal fusion,        especially for patients who have a fusion.    -   6) Provides long term durability, and facilitates repeated        surgeries of the spine.

SUMMARY OF THE INVENTION

In one aspect, the present invention provides a surgical kit. The kitcan include a shield for covering a portion of the spine of a subject.The shield can include an attachment portion adapted to engage a bonefixation assembly which is adapted to be fixated on multiple vertebrabones of the subject.

In one embodiment, the bone fixation assembly comprises at least onevertebra joining member secured between two bone anchors, each boneanchor comprising a fastener portion adapted to be implanted into avertebra bone and a head coupling portion adapted to secure the vertebrajoining member.

In another embodiment, the attachment portion of the shield is adaptedto engage the vertebra joining member of the bone fixation assembly. Inalternative embodiments, the attachment portion of the shield is adaptedto engage at least one of the bone anchors of the bone fixationassembly.

Alternatively, the attachment portion of the shield includes a hookportion for engaging the vertebra joining members of the bone fixationassembly. The bone fixation assembly may comprise a bone screw or morethan one bone screw connected by a vertebral joining member. Thevertebral joining member may be a rod, which may have a telescopingconfiguration.

In some embodiments, the shield has an adjustable transverse width. Inone embodiment, the shield includes two parts each containing one hookfor engaging a vertebra joining member of the bone fixation assembly,where the two parts are adapted to engage each other at multiple lateralpositions. In one embodiment, there are two hooks which are configuredto removably attach to the rod, and a connecting member is disposedbetween the two hooks.

The connecting member may comprise two connecting members slidablyjoined at a center screw.

The shield may have a vertical length to cover at least two or morevertebrae. The shield may also comprise a plurality of shields, whereadjacent shields are stacked in a continuous manner one on top of theother.

The shield may be included in a surgical kit that includes at least onecoupling element adapted to secure the attachment portion of the shieldto one of the bone anchors. The surgical kit may further include atleast one coupling element adapted to secure the attachment portion ofthe shield to the vertebra joining member. In these embodiments, thecoupling element may be a clip having an open end. In one embodiment,the clip may have an omega type shape. The coupling element may beremovably attached to a bone screw. In some embodiments, the attachmentportion comprises a coupling element comprising two side hooks and aconnecting member.

In yet another embodiment, the bone fixation assembly comprises at leasttwo vertebral joining members each secured between two bone anchors. Thesurgical kit further includes a link adapted to engage each of the twovertebra joining members. The link may include a securing element tosecure the shield thereon. In one embodiment, the link can include twoconnecting members in a slidable configuration with each other so as toallow adjustment of a transverse length of the link across the vertebra.In one embodiment, the shield includes two parts each affixed to arespective member of the two connecting members of the link, and alateral distance between the two parts can be adjustable as the twoconnecting members of the link are moved relative to each other.

The attachment portion of the shield can include at least one hole. Theshield can include an elongated concavity. The attachment portion caninclude two parts extending laterally on opposite sides of the shield.

In one embodiment, the shield comprises two lateral parts, each lateralpart comprises a shield portion and a hook portion, the shield is fixedto a bone fixation assembly by an attachment portion, and the attachmentportion is configured to removably attach to the bone fixation assembly.

In one embodiment, the shield comprises two half-domes, where eachhalf-dome is fixed to one connecting member.

The shield can include or is made from a polymeric material, such asPEEK. In other embodiments, the shield may include a metallic or metalalloy material, such as titanium or its alloys.

The shield can further include at least one therapeutic agent such as ananti-stenotic agent, an anti-fibrotic agent or an antibiotic agent.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1A (prior art) is a partial perspective view of a lumbar vertebraeshowing a body dissection associated with a laminectomy.

FIG. 1B (prior art) is a partial perspective view showing use of a priorart shield to cover the laminectomy dissection shown in FIG. 1A.

FIG. 2A is a perspective view of a spine protection shield of anembodiment of the present invention; FIG. 2B is a top view of the spineprotection shield shown in FIG. 2A;

FIG. 2C is a top view of a spine protection shield of another embodimentof the present invention; FIGS. 2D and 2E are top views of spineprotection shields having different attachment portions according toembodiments of the present invention.

FIG. 3 depicts a bone fixation assembly as implanted on vertebra bonesof a portion of the spine of a subject where a laminectomy has beenperformed.

FIG. 4 depicts an exemplary internal structure of an anchor of a bonefixation assembly.

FIG. 5 depicts a spine protection shield installed on a laminectomy sitevia a bone fixation assembly according to certain embodiments of thepresent invention.

FIGS. 6A-6M depict various configuration of a coupling element forsecuring a spine protection shield onto a vertebra joining member of abone fixation assembly, according to embodiments of the presentinvention.

FIGS. 7A and 7B depict coupling a spine protection shield with an anchorof a bone fixation assembly, according to embodiments of the presentinvention.

FIGS. 8A-8I depict various configurations of an attachment portion of aspine protection shield that includes structural features for engaging aportion of a bone fixation assembly, according to embodiments of thepresent invention.

FIGS. 9A and 9B depict an embodiment of the invention.

FIGS. 10A and 10B depict a mechanism of attachment of the invention tothe vertebral column.

DETAILED DESCRIPTION

The present invention generally relates to a surgical kit which includesa shield adapted to cover a portion of the spine of a subject, e.g.,after laminectomy or after a posterior spinal fusion. The shieldincludes an attachment portion adapted to engage a bone fixationassembly which is adapted to be fixated on multiple vertebra bone of thesubject. The attachment portion can removably attach to the bonefixation assembly.

An example of the shield is shown in FIGS. 2A and 2B. The shield 100 caninclude a body portion 100, which can take an arcuate shape, 110 (e.g.,curved, elliptical or trapezoidal in shape) or have an elongatedconcavity, as well as attachment portions 120 a and 120 b, which mayinclude holes or openings 122 a and 122 b to accommodate attachment pinsor other coupling mechanism for fixation of the shield onto bone (i.e.,vertebra). The hole can assume a circular, elliptical, square or othershape. Although the attachment portions 120 a and 120 b are shown toeach include two holes; fewer or more holes can be included to providealternative choices for fixation (an example of the shield having onlyone hole on each attachment portion is shown in FIG. 2C), e.g., 3, 4, 5,6, 7, 8, 9, 10 . . . n. The shield 100 may be symmetrical with respectto an axis 101, where the attachment portions extend laterally onopposing sides with respect to the axis 101. In use, the axis 101 can bealigned with the spine in a vertical, axial path. The shield 100 has alength L along the axis (or vertical length) which can be configured tocover one vertebrae, or two, or more consecutive vertebrae of differentsections (e.g., cervical, thoracic, lumbar, etc.) of the spine or spinalcolumn, as desired or needed, e.g., 3, 4, 5, 6, 7, 8, 9, 10, vertebra.The shield 100 has a total width W and the body of the shield has awidth of W1, both of which can be selected or tailored to suite thelocation of the shield on the spine where the shield is to be implanted.As shown below, in certain embodiments, the width W and/or W1 can beadjustable.

Alternatively, the attachment portions can have no holes, but insteadinclude other structural features that help secure the shield onto thebone fixation assembly. The means for securing the shield to the bonefixation assembly is described further below. There can also be multipleattachment portions on either lateral side of the shield 100, and theattachment portions can take various shapes and sizes, as illustrated inFIG. 2D (120 a, 120 b, 120 a′, 120 b′) and FIG. 2E (120 c, 120 d).

As described herein, the protection shield is configured to engage abone fixation assembly, which can be part of the surgical kit, orprovided separately. In one embodiment, and as illustrated in FIG. 3 , abone fixation assembly 200 can include a vertebra joining member 220 asecured between two bone anchors 231 a and 232 b, and a vertebra joiningmember 220 b secured between two bone anchors 232 a and 232 b. The boneanchors can be implanted into a portion of the transverse process 27 aand 27 b of the respective vertebra 26 a and 26 b. The vertebra joiningmember 220 a/220 b between the anchors 231 a-232 a and between theanchors 231 b-232 b help inhibit the relative motion between the twovertebra 26 a and 26 b. While shown as being cylindrical, the vertebrajoining member 220 a/220 b can have any desired cross section shapes,such as elliptical, rectangular or other multilateral shapes. Also shownin FIG. 3 is a cut lamina 42 (the spinal process and part of the laminahave been removed) from which a portion of the spinal cord 24 isexposed. The shield of the present invention, which when in use, cancover (without touching) this portion of the exposed spinal cord 24 andcan attach to the bone fixation assembly 200. For a simple laminectomywithout spinal fusion, a protection shield 100 shown in FIG. 2 can alsobe simply fixated on the remaining bone (or residual lamina) or medialfacet joint using cortical screws which are inserted through the holes122 a and/or 122 b.

The bone fixation assembly illustrated in FIG. 3 can take variousconfigurations. For example, FIG. 4 depicts an illustrative crosssection view of an embodiment of the bone fixation assembly shown inFIG. 3 . The anchor 210 a includes a fastener portion 250, which may bea bone screw having a head portion 251 and a threaded portion 252 forfacilitating its implantation into vertebra bone (e.g., a transverseprocess portion of the vertebra 26 a shown in FIG. 3 ). The fastenerportion 250 includes a receptacle 254 which can be used to drive thethreaded portion into the bone, e.g., by a screw driver or othermechanical device. The anchor 210 a further includes a head couplingportion 260, which includes a housing 262 and a locking member 264 whichcan be configured to engage with an inner surface 263 of the housing 262with mating threads, and lock the vertebra joining member 220 a intoplace by friction. In one embodiment, the bone fixation assemblycomprises two bone screws which are connected by a vertebral joiningmember. The vertebra joining member may be removably attached to the oneor more bone screws.

In the embodiments shown in FIGS. 3 and 4 , when the locking member 264is in the unlocked position (e.g., when it is not contacting thevertebra joining member 220 a), the vertebra joining member 220 a can bemoved along its length direction, allowing adjustment of the length ofthe vertebra joining member 220 a disposed between the two anchors 231 aand 232 a (and between the two anchors 231 b and 232 b). The vertebrajoining member can be a rod. Alternatively, the vertebra joining memberscan have a telescoping configuration along its long axis; thistelescoping configuration allows adjustment of the lengths of thevertebra joining member 220 a disposed between the two anchors 231 a and232 a after two ends of the vertebra joining member 220 a have beenlocked onto the respective anchors.

Additionally, the anchor 210 a may include a link 270 connecting thehead coupling portion 260 and the fastener portion 250 with a doubleball and socket joint configuration which allows for rotation and/orpivoting of the head coupling portion 260 relative to the axis of thefastener portion 250. A passage 272 is defined within the link 270,which is aligned with the receptacle 254 of the fastener portion 250, toallow a tightening tool, e.g., a screw driver, to directly contact thereceptacle 254 through the head coupling portion 260 (before thevertebrae joining member 220 a is installed) to secure the fastenerportion 250 into the bone.

The shield of the present invention can engage the bone fixationassembly in various ways. For example, the attachment portion of theshield can be fixed onto the vertebra bone by the fastener portion 250as shown in FIG. 3 , e.g., by inserting the threaded portion 252 througha hole of the attachment portion, thereby allowing the head portion 251to secure the attachment portion 120 a or 120 b of the shield onto thevertebra bone.

In a preferred embodiment, the shield is secured on the bone fixationassembly after the bone fixation assembly has already been implanted. Asillustrated in FIG. 5 , the shield 100 can be secured to the rods of thebone fixation assembly (which has already been installed on bone) viathe attachment portions 120 a/120 b. This approach allows easyinstallation and rapid as well as replacement of the shield whilekeeping the fixation assembly in place.

To facilitate securement of the shield onto the bone fixation assembly,the protection shield can include an attachment portion (s) that isshaped and configured to directly engage the bone fixation assembly(e.g., on the rods or on the bone anchors). Alternatively, the surgicalkit can include one or more coupling elements to couple an attachmentportion of the shield to the bone fixation assembly, e.g., to thevertebra joining member, and/or to the head coupling portion(s) of thebone fixation assembly 200. Preferably, the coupling element is securedon the vertebra joining member 220 at a position between the two boneanchors associated with the vertebra joining member.

As illustrated in FIG. 6A, a coupling element to secure the attachmentof the vertebra joining member can take a form of a clip 310. The clipcan be configured with appropriate elasticity and contour length to wraparound at least a portion of the circumference of the vertebra joiningmember of the bone fixation assembly so as to secure the attachmentportion against the vertebra joining member 220. FIG. 6B illustrates ashield 100 being secured to the vertebra joining member 220 by insertingthe clip 310 through a hole 122 b of an attachment portion of the shield100 and wrapping around a circumference of the vertebra joining member220.

As illustrated in FIG. 6C, the coupling element can also take a form ofa clip 320 having an open end, or an omega (“Ω”) shape, which includes abulbous portion 322 having an opening width of Wb, a neck portion 324having an opening width Wn (Wn<Wb), and a flared end portion 326. FIG.6D illustrates a shield 100 being secured to the vertebra joining member220 by inserting the clip 320 through a hole 122 of an attachmentportion of the shield 100 and wrapping it around a circumference of thevertebra joining member 220. Preferably, the size, configuration, andelasticity of the omega (“Ω”) shape shaped clip 320 are such that thebulbous portion 322 can wrap around at least more than 180° of thecircumference of the vertebra joining member 220, and that the width Wnof the neck portion 324 when the clip 320 is secured on the vertebrajoining member 220 is smaller than the diameter of the vertebra joiningmember 220. The advantage of the omega (“Ω”) shape configurationincludes easy deployment of the clip 320. An operator can push the openend toward the vertebra joining member 220, and the open end would beexpanded due to the elasticity of the clip 320, thereby allowing thebulbous portion 322 to snap-fit on the circumference of vertebra joiningmember 220, with the aid of the neck portion 324 to lock the vertebrajoining member 220 into place by friction.

As illustrated in FIG. 6E, the coupling element can also take a form ofa clip 330 having a locking mechanism near the ends of the clip. Clip330 includes an elongate member 332, a protruded portion 336 near oneend of the elongate member 332, and a port 334 near the other end of theelongate member 332. The protruded portion 336 is configured withappropriate dimension to be inserted into the port 334 to form a closedstructure where the protrusion 336 frictionally engages the port 334.The closed structure can be reopened manually if needed, but otherwisehas sufficient stability to be implanted into the body for long termuse. The contour length of the elongate member 332 between the protrudedportion 336 and the port 334 can be tailored to be sufficient to wraparound the circumference of the vertebra joining member to allow theinsertion of protruded portion 336 into the port 334. FIG. 6Fillustrates a shield 100 being secured to the vertebra joining member220 by inserting the elongate member 332 of a clip 330 through a hole122 b of an attachment portion of the shield 100 and wrapping it arounda circumference of the vertebra joining member 220, and the protrudedportion 336 is locked in the port 334 to form a closed structure tosecure the shield onto the vertebra joining member 220.

In another embodiment, as illustrated in FIGS. 6G and 6H, the couplingelement can take the form of a link 340 that is configured to spantransversely over the vertebra to engage the vertebra joining members(rods) of the bone affixation assembly installed on both sides of thespine (see FIG. 3 ). The link 340 includes lateral or side hooks 348 aand 348 b dimensioned and configured to engage the vertebra joiningmembers (rods). Each hook also is equipped with screws 344 a/344 b fortightening against the respective rod. A connecting member 346 b extendsfrom hook 348 b. The distal end of the connecting member 346 b includesan enlarged portion 345 for receiving a center screw 342, and a hoopstructure 343 for slidably receiving a connecting member 346 a extendingfrom the hooks 348 a/348 b. The transverse length LL between the hooks348 a and 348 b is adjustable by virtue of a slidable connection betweenthe two connecting members 346 a and 346 b. The connecting member 346 acan rotate within the hoop 343, and the two connecting members 346 a and346 b can also deviate from a linear arrangement (e.g., they can form anangle), thereby permitting the link 340 to couple with the vertebrajoining members of the bone fixation assembly that might not be parallelconfiguration. In operation, when desired length LL and other adjustableparameters of the configuration of the link 340 are obtained (e.g., whena tight fit between the hooks and vertebra joining member are obtained),the center screw 342 can be tightened to engage connecting member 346 athereby fixing the length LL. The screws 344 a and 344 b can betightened so that they securely engage the vertebra joining member(rods) of the bone fixation assembly. FIG. 6H shows the coupling element340 as secured on the vertebra joining members 220 a/220 b of the bonefixation assembly.

The shield of the present invention can be secured in various ways. Forexample, as schematically illustrated in FIG. 6I, the shield 100 canhave multiple apertures 125 a, 125 b, and 125 c positioned along itslong or vertical axis, e.g., along the longitudinal axis 101 of shield100, where the size of the apertures is adapted such that screw 342 ofthe link 340 can be inserted through the apertures to secure the shield100 thereon. As illustrated in FIG. 6J (a top down view of the shield100 assembled on three links), shield 100 is secured by three links 340a, 340 b, and 340 c via center screws 342 a, 342 b, and 342 c of thelinks (the three links 340 a, 340 b, and 340 c are secured to therespective rods 220 a and 220 b by their respective side hooks). Thus,when the center screws 342 a, 342 b, and 342 c are tightened, thelateral span of the links 340 a, 340 b, and 340 c is fixed, and theshield 100 is secured to the vertebra at the same time.

FIGS. 6K and 6L illustrate an alternative example where the couplingelement takes the form of a link 340 as previously described inconnection with FIGS. 6G and 6H. In this embodiment, a shield 100 caninclude two parts 100 a and 100 b, which assume a configuration of ahalf-dome or curved shell with a cut top 100 a 1 and 100 b 1,respectively. Parts 100 a and 100 b can be fixed on the connectingmembers 346 a and 346 b of the link 340, respectively. The fixation canbe accomplished by mechanical coupling, chemical bonding, physicalbonding, etc. The lateral distance between the two parts 100 a and 100 bof the shield can be adjusted by sliding the connecting member 346 arelative to the connecting member 346 b. For example, when the twolateral hooks 348 a and 348 b are in a first, open configuration, asshown in FIG. 6K, there is a lateral gap Dg between the two parts 100 aand 100 b of the shield. After the two connecting members 346 a and 346b are slid against each other such that the two lateral hooks 348 a and348 b are in a second, more compact configuration, as shown in FIG. 6L,the two parts 100 a and 100 b meet in a center seam 100 s or at leastpartially overlap in the middle such that there is no longer a lateralgap between the two parts 100 a and 100 b. In this configuration, theupper portion of the shield 100 can mimic the shape of a spinousprocess. This configuration can also be used as a final assembledconfiguration for implantation, at which the connecting members 346 aand 346 b can be locked against each other by tightening the screw 342by a tightening tool (e.g., a screw driver) which can access the screw342 via the top opening 100 h formed by the two parts 100 a and 100 b atthis configuration.

In the above embodiments where a coupling element is used to couple theshield onto the vertebra joining member, for improved friction betweenthe coupling element and the vertebra joining member, the vertebrajoining member can include grooves, dents, dimples, or other surfaceirregularities.

In another embodiment, illustrated in FIG. 6M, the coupling elementtakes the form of a link 350 that is configured to span transverselyover the spine to engage the vertebra joining members (rods) of the bonefixation assembly which are installed on both sides of the spine. Thelink 350 includes lateral or side hooks 358 a and 358 b dimensioned andconfigured to engage the vertebra joining members (rods). The hook hasan open end which can be in the form of an “Ω” (omega) shape. Aconnecting member 356 b extends from hook 358 b; a connecting member 356a extends from hook 358 a. The distal end of the connecting member 356 bincludes an elongated port 355 for receiving a bolt 352 which isattached to connecting member 356 a; the bolt extends upward through theport 355 to slidably connect connecting members 356 a and 356 b. Thetransverse length LL between the hooks 358 a and 358 b is adjustable dueto the slidable connection between connecting members 356 a and 356 b.The connecting members 356 a and 356 b can rotate with respect to eachother to form a non-linear arrangement. For example, the connectingmembers can move to form an angle between them which is less than 180°.Bolt 352 can be tightened to engage connecting member 356 a withconnecting member 356 b, thereby fixing the length LL.

In other embodiments, the coupling element can be configured forcoupling the attachment portion of the shield 100 directly with the boneanchors of the bone fixation assembly. As another example, these clipscan be used to couple to the head coupling portion 260 as shown in FIG.4 . Other forms of coupling elements can also be used. For example,FIGS. 7A and 7B show an attachment pin (or stud/screw) 380 having a headportion 382, an engaging portion 384 dimensioned and configured to beinserted into the socket 265 of the locking member 264 of the headcoupling portion 260 (see FIG. 4 ) through a hole 122 a/122 b of anattachment portion 120 a, 120 b of a shield, thereby securing theattachment portion 120 a, 120 b of the shield onto the head couplingportion 260.

In further embodiments, an attachment portion of the shield of thepresent invention can include an integral portion which is configured toengage the bone fixation assembly. For example, the various couplingelements (clips) as shown in FIGS. 6A, 6C, and 6F can be fabricated aspart of an attachment portion of the shield 100, or integrated with anattachment portion of the shield 100. As illustrated in FIG. 8A, anomega (“Ω”) shape shaped clip 420 can be manufactured separately fromthe shield 100 and then integrated or joined with an attachment portion120 of the shield 100 (e.g., by welding, adhering, or other commonlyknown techniques in the art). FIG. 8B illustrates a shield 100 having anattachment portion 120 which includes an omega (“Ω”) shape shaped endportion 430. The clip 420 or omega (“Ω”) shape shaped end portion 430can be used for engaging a vertebra joining member 220, or a bone anchorassociated with a vertebra joining member 220. While the open end of theclip 420 or omega (“Ω”) shape shaped end portion 430 is shown in FIGS.8A and 8B as being oriented laterally toward the vertebra joining member220, other orientations are also contemplated, for example, downward, orobliquely downward.

An attachment portion of the shield of the present invention can alsoinclude other integral structural element configured to engage a part ofthe bone fixation assembly other than the vertebra joining member(s).For example, as illustrated in FIG. 8C, the attachment portion 120 of ashield 100 includes a protruded portion 440 which is dimensioned andconfigured, such as the attachment pin 380 in FIGS. 7A and 7B, to beinserted into the socket 265 of the locking member 264 of the headcoupling portion 260, thereby securing the attachment portion 120 of theshield 100 onto the head coupling portion 260.

FIG. 8D illustrates another example of attachment portions 120 a and 120b of shield 100 configured as hooks to engage vertebra joining members220 a and 220 b on both lateral sides. In this embodiment, the shield100, the attachment portions 120 a/120 b are formed from two pieceswhich are joined together. FIG. 8E illustrates a variation of thestructure shown in FIG. 8D, where attachment pins 180 a and 180 b (e.g.,screws) located proximal to the hooks can be fastened to contact thevertebra joining members (rods) 220 a and 220 b, thereby providingfurther security for the engagement between the hooks and the vertebrajoining members (rods) 220 a and 220 b.

FIGS. 8F-H illustrate a further example of attachment portions 120 a and120 b of shield 100 configured as hooks, where the shield 100 has anadjustable transverse or lateral width. In this embodiment, the shield100 includes two lateral parts (or halves) 100 a and 100 b, eachincluding a slit 102 a and 102 b oriented along the width direction. Toassemble the shield during surgery, the operator can first engage thetwo respective hooks with the vertebra joining members of the bonefixation assembly (not shown), and slide the two halves of the shieldtoward each other until a desired position is reached where the twohalves are partially overlapping with each other with the slits 102a/102 b aligned. Then the operator can secure the shield at thisposition (see FIG. 8F) using an attachment pin 181 through the openingof the slits 102 a and 102 b. The attachment pin 181 can include a bolt181 a and nut 181 b. Instead of the slits 102 a/102 b, a series of holes103 a/103 b arranged in the width direction on 100 a and 100 b can alsobe employed (see FIG. 8H) to provide discrete stop positions foradjusting the width of the shield to cover the vertebra.

In another embodiment, and as shown in FIG. 8I, the coupling mechanismof the coupling element or link can take the form of a series ofprotrusions configured to mate with a series of apertures. The couplingelement is configured to span transversely over the spine to engage thevertebra joining members (rods) of the bone affixation assembly (notshown). In this case, securement between the two halves of the shieldcan be accomplished by directly coupling between the protrusions and theapertures. The coupling mechanism 360 includes lateral or side hooks 368a and 368 b dimensioned and configured to engage the vertebra joiningmembers (rods). A connecting member 366 a extends from hook 368 a and aconnecting member 366 b extends from hook 368 b. Connecting member 366 bcomprises a series of protrusions 364, which may be evenly spaced alongits length. Connecting member 366 a comprises a series of apertures 365,which may be evenly spaced along its length, and which are configured tomate with the protrusions 364 of connecting member 366 b. Theprotrusions 364 should be flush with the external surface of theapertures 365. The transverse length LL between hooks 368 a and 368 b isadjustable with respect to the mating, or joining, of the protrusions364 and the apertures 365, which can adjust such that one or more thanone protrusion is mated with one or more than one aperture.

FIGS. 9A and 9B illustrate an embodiment of the coupling element of FIG.6M attached to a spine. FIG. 9A shows the invention with the couplingelement in a closed position while FIG. 9B shows the invention with thecoupling element in a open position. As previously described, thecoupling element may be in the form of a link 350 configured to spantransversely over the vertebra of the spine to engage the vertebraljoining members (rods) 200 installed on either side of the spine. Thelink 350 comprises side hooks 358 a and 358 b dimensioned and configuredto engage the vertebra joining members 200. The link 350 furthercomprises a connecting member 356 b extending from hook 358 b andconnecting member 356 a extending from hook 358 a. The distal end of theconnecting member 356 a comprises a bolt 352 and the distal end of theconnecting 356 b comprises an elongated port 355 for receiving the bolt352 to slidably connect the connecting members. The shield 370 can beattached on top of the coupling mechanism. The arrangement of the shield370 and the vertebral coupling element allows the shields to stack oneon top of the other to form a continuous, yet flexible shield along thespinal column.

As illustrated in FIGS. 9A and 9B, the surgical kit may comprise oneshield or may comprise more than one shield. For example, the surgicalkit may comprise 2, 3, 4, . . . , n shields. When using more than oneshield, the shields become stacked one above the other along the spinalcolumn. Each shield is designed to cover one vertebra. If more than onevertebra needs to be covered, then more than one shield would beemployed with each shield covering one vertebra.

FIGS. 10A and 10 B illustrate the attachment of the present invention toa bone fixation assembly. In FIG. 10A, an embodiment of the shield 370is connected to the caudal ridge of the spinous process through theconnection of the hooks 358 a and 358 b to the vertebra joining members(rods) 200. FIG. 10B shows an embodiment of the shield 370 when thedistance between the spinous process and the shield is closed and theinvention is snapped to the cephalad ridge.

In the various embodiments illustrated above, the bone fixationassembly, the coupling element that couples the bone fixation assemblywith the shield, as well as the shield, can be made from variousbiocompatible materials, such as metal, metal alloys, polymericmaterials, including bioabsorbable materials such as polylactic acid,polyglycolic acid, poly-ε-caprolactone, or mixtures or copolymersthereof. Examples of materials that may be used include stainless steel(SST), nickel titanium (NiTi), or polymers. Examples of other metalswhich may be used include, super elastic NiTi, shape memory NiTi, Ti—Nb,Ni—Ti approx. 55-60 wt. % Ni, Ni—Ti—Hf, Ni—Ti—Pd, Ni—Mn—Ga, 300 to 400series 304, 316, 402, 440 SST, MP35N, 17-7 PH SST, other spring steel orother high tensile strength material or biocompatible metal material. Inone preferred embodiment, the material is super elastic or shape memoryNiTi, while in a second preferred embodiment, the preferred material isSST.

Alternatively, the shield may be formed from polymers. Examples ofpolymers include polyimide, PEEK, nylon, polyurethane, polyethyleneterephthalate (PET), latex, HDHMWPE and thermoplastic elastomers.

Depending on the material as well as the structural requirements interms of flexibility, the wall thickness of the shield at any point canvary, e.g., from about 0.05 mm to 2 mm, e.g., 0.05 mm to about 1 mm,about 0.1 mm, 0.2 mm, 0.3 mm, 0.4 mm, 0.5 mm, 0.6 mm, 0.7 mm, 0.8 mm,0.9 mm, 1.0 mm, etc. The inner diameter of the shield can vary, e.g.,from about 0.1 mm to about 2 mm, or from about 0.25 mm to about 1 mm,e.g., about 0.2 mm, about 0.3 mm, about 0.4 mm, about 0.5 mm, about 0.6mm, about 0.7 mm, about 0.8 mm, about 0.9 mm, about 1 mm, about 2 mm,about 2.5 mm, about 3 mm thickness.

The spine protection shield 100 can be impregnated or coated with one ormore therapeutic or pharmaceutical agents, such anti-restenotic agents,anti-fibrotic agents, or anti-inflammatory agents, antibiotics, orcombinations of any of these agents. Such agents can be impregnated in acontrolled-release layer which is coated on the protection shield. Thecontrolled release layer can be formed from proteins such as collagen,fibrin, tropoelastin, elastin, cross-linked tropoelastin andextracellular matrix component, fibrin, fibronectin, laminin,derivatives thereof, or other biologic agents or mixtures of any ofthese.

The therapeutic or pharmaceutical agent can be encapsulated, embedded orsuspended in a biocompatible matrix such as a gel. The gel may be ahydrogel which can be dried and re-hydrated. The matrix can beencapsulated by a cover, which could be semipermeable. The cover may bea membrane, sheet, film, tape or any other desired configuration whichis semipermeable.

The cover may have a plurality of holes, pores, slits, or can be formedfrom a porous network of fibrils, or from a variable density fibrilmatte, or any other desired perforations. The therapeutic orpharmaceutical agent can be uniformly delivered over a period of time t.Alternatively, the therapeutic or pharmaceutical agent is released at arate independent of time and the concentration of the pharmaceuticallyactive agent incorporated in the present device. Zero-order releaseensures that a steady amount of drug is released over desired length oftime, minimizing potential peak/trough fluctuations and side effects,while maximizing the amount of time the drug concentrations remainwithin the therapeutic window.

The layer incorporating the therapeutic or pharmaceutical agent may be acoating on the exterior surface of the lamina cover. The layerincorporating the agent may also be wrapped around the lamina coverusing a spiral tape configuration. The layer or coating from the agentloaded matrix can be applied to the lamina cover using standardtechniques to cover the entire or partial surface of the lamina cover.The coating may be a single layer of a homogenous mixture of drugs and amatrix, or in a composition dot matrix pattern. The lamina cover may bedipped or sprayed with a liquid solution comprising at least onepharmaceutical or therapeutic agent. After each layer is applied, thelamina cover is dried before application of the next layer. Thethickness of the layer incorporating the therapeutic or pharmaceuticalagent may range from about 0.1 μm to about 150 μm, from about 1 μm toabout 100 μm, from about 10 μm to about 50 μm, or from about 20μ to 30μm. Alternatively, multiple layers of the active agent/matrixcomposition can be applied on the surface of the cover in thesethickness ranges. For example, multiple layers of variouspharmaceutically active agents can be deposited onto the cover so that aparticular drug can be released at one time.

The layer or coating incorporating the pharmaceutical agent may alsocomprise a matrix. The matrix may comprise a water soluble material orwater-swellable material. The therapeutic or pharmaceutical agent may bedispersed within the matrix or coated on the exterior and/or interiorsurfaces of the matrix. Water soluble material refers to material thatdissolves, hydrolyzes, breaks down or disintegrates in contact withwater or aqueous physiological fluid, such as blood and interstitialfluid. As the water soluble material layer dissolves, the therapeutic orpharmaceutical agent is released. The length of time that is needed forthe water soluble material to be dissolved may be less than 2 hours,less than 1 hour, less than 30 minutes, less than 10 minutes, less than5 minutes, or less than 1 minute.

The matrix may comprise a mixture of water insoluble and water solublematerials. Examples of the combinations include shellac andolyvinylpyrollidone, and ethyl cellulose and hydroxypropylmthylcellulose. The matrix may also comprise water swellable material. Watersoluble or water swellable material may comprise a polysaccharide, suchas dextral, alginate, amylose, amylopectin, carrageenan, carboxylmethylcellulose, gellan, guar gum, polysaccharide conjugate vaccines,hydroxylethyl cellulose, amylopectin, starch derivatives, hyaluronicacid, starch derivatives, xantan, xyloglucan, chitosan-based hydrogel,peptidoglycan, and progeogl yeans. Water soluble or water swellablematerial may also comprise a simple carbohydrate, such as glucose,maltose, lactose, fructose, sucrose, galactose, e glucosamine,galactosamine, muramic acid, glucruronate, gluconate, fructose,trehalose, a synthetic polymer, such as polyvinyl alcohol,polyvinylpyrrolindone, polyethylene glycol, propylene glycol,polyoxyethylene derivatives, a polypeptide, such as elastin, polyvinylamine or poly(L-lysine), uncrosslinked hydrogel, crosslinked hydrogel,polyacrylic acid or any other cross-linked water swellable polymers.Examples of hydrogel materials include carboxymethyl cellulose (CMC),hydroxypropylmethyl cellulose (HPMC), amylopectin, starch derivatives,hyaluronic acid, or their combinations.

The matrix that incorporates the pharmaceutically active agent may alsocomprise many desired biocompatible, non-toxic material. Examples ofbiocompatible materials include poly(lactide-co-glycolide), polyesterssuch as polylactic acid, polyglycolic acid, polyanhydride,polycaprolactone, polyhydroxybutyrate valerate, or mixtures ofcopolymers thereof. In one embodiment, the matrix may further comprisenaturally occurring substances such as collagen, fibronectin,vitronectin, elastin, laminin, heparin, fibrin, cellulose, carbon orextracellular matrix components. Polymers which can be used in thematrix include poly(lactic-co-glycolide); poly-DL-lactide,poly-L-lactide, and/or mixtures thereof and can be of various inherentviscosities and molecular weights. In one embodiment, poly(DLlactide-co-glycolide) can be used. The poly-DL-lactide material can bein the form of homogenous composition and when solubilized and dried, itcan form a lattice of channels in which pharmaceutical or therapeuticsubstances can be trapped for delivery to the tissues. In a furtherembodiment, the coating composition comprises a nonabsorbable polymer,such as ethylene vinyl acetate (EVAC), polybutyl-methacrylate (PBMA) andmethylmethacrylate (MMA).

The matrix may also comprise an organogel, such as poly(ethylene),L-alanine, sorbitan monostearate, Eudragit or lecithin organogel.Alternatively, the gels may comprise a sol-gel. In another embodiment,the matrix may comprise a tape such as bioadhesive which can be wrappedaround the lamina cover. For example, an alkyl cyanoacrylate monomerwhich polymerizes into a thin flexible film may be used. Alkyl chaincyanoacrylates such as methyl-, ethyl-, isopropyl, butyl andoctylcyanoacrylate may be used. Other possible bioadhesives include,urethane-based materials as well as adhesives incorporating musseladhesive proteins.

The layer or coating incorporating the therapeutic or pharmaceuticalagent may be dispersed within and or onto a sponge-like membrane orlayer, made of a non-hydrogel polymer having a plurality of voids. Thesponge like membrane or layer alternatively may also be constructed outof a polymer based fiberal network or scaffolding, resulting in voidspaces existing within this fiberous or fiberal nodal network. Thetherapeutic or pharmaceutical agent is infused into the voids of thesponge membrane or layer that overlies that lamina cover. Thetherapeutic or pharmaceutical agent is expelled through the voids of thesponge membrane or layer. The sponge membrane or layer may be preparedby dissolving a non-hydrogel polymer in a solvent and an elutableparticulate material. After the sponge membrane or layer composition iscured, it is exposed to a solvent, e.g. water, which causes theparticulate material to elute from the polymer, leaving a spongemembrane or layer having a plurality of voids therein. The spongecoating is then exposed to a biologically active material to load thesponge membrane or layer with such material. Such material may be loadedinto the coating by diffusion or other means. The non-hydrogelpolymer(s) useful for forming the sponge membrane or layer should beones that are biocompatible. Non-hydrogel polymers are polymers thatwhen a drop of water is added on top of a film of such polymer, the dropwill not spread. Examples of such polymers include, without limitation,polyurethanes, polyisobutylene and its copolymers, silicones, andpolyesters. Other suitable polymers include polyolefins,polyisobutylene, ethylene-alphaolefin copolymers, High Density HighMolecular Weight Polyethelene (HDHMWPE), acrylic polymers andcopolymers, vinyl halide polymers and copolymers such as polyvinylchloride, polyvinyl ethers such as polyvinyl methyl ether, polyvinylhalides such as polyvinylidene fluoride and polyvinylidene chloride,polyacrylonitrile, polyvinyl ketones, polyvinyl aromatics such aspolystyrene, polyvinyl esters such as polyvinyl acetate; copolymers ofvinyl monomers, copolymers of vinyl monomers and olefins such asethylene-methyl methacrylate copolymers, acrylonitrile-styrenecopolymers, ABS resins, ethylene-vinyl acetate copolymers, polyamidessuch as Nylon 66 and polycaprolactone, alkyd resins, polycarbonates,polyoxyethylenes, polyimides, polyethers, epoxy resins, polyurethanes,rayon-triacetate, cellulose, cellulose acetate, cellulose butyrate,cellulose acetate butyrate, cellophane, cellulose nitrate, cellulosepropionate, cellulose ethers, carboxylmethyl cellulose, collagens,chitins, polylactic acid, polyglycolic acid, and polylacticacid-polyethylene oxide copolymers.

The therapeutic or pharmaceutical agent may be incorporated intomicrospheres, liposomes, and other types of particle-based drug deliveryvehicles which are incorporated in the matrix. For example,Poly(lactic-co-glycolic acid) nanoparticles can be incorporated within across-linkable hyaluronan-based hydrogel matrix. Alternatively, thematrix may comprise a nanogel for encapsulating the therapeutic orpharmaceutical agent. Nanogels are a polymer network of chargedpolyionic segments crosslinked by polyethylene glycol (PEG) segments. Awide variety of different pharmaceutical agents can be incorporated intothe nanogel.

Examples of anti-restenotic agents include but are not limited to,taxol, a pharmaceutically active taxol derivative, rapamycin, apharmaceutically active rapamycin derivative, synthetic matrixmetalloproteinase inhibitors such as batimastat (BB-94), acell-permeable myotoxins such as cytochalasin B, gene-targetedtherapeutic drugs, c-myc neutrally charged antisense oligonucleotidessuch as nonpeptide inhibitors such as tirofiban, antiallergic drugs suchas tranilast, gene-based therapeutics such as paclitaxel, andcombinations thereof).

Examples of anti-fibrotic agents include but are not limited to, anagent that degrades or causes the dissolution or shrinkage of fibrotictissue or a portion thereof; an agent that enzymatically degrades orshrinks the fibrotic tissue, such as protease or glycanase; a hormone,such as relaxin, which inhibits collagen production and stimulatescollagen degradation; a cytokine, drug, cell, or nucleic-acid-basedmaterial that influences the function, viability, or proliferation offibroblasts or other cells in the fibrotic tissue; or cells that inhibitcollagen production and/or stimulates collagen degradation. Specificexamples of anti-fibrotic agents include alginate, chondroitin sulfate,dermatan sulfate, dextran sulfate, hyaluronic acid, heparin, heparinsulfate, keratin sulfate, and pentose polysulfate, or combinationsthereof.

Examples of anti-inflammatory agents (in cases where no spinal fusion isinvolved, as anti-inflammatory would impede spinal fusion) include butare not limited to naproxen; diclofenac; celcoxib; sulindac; diflunisal;piroxicam; indomethacin; etodolac; meloxical; ibuprofen; ketoprofen;r-flurbiprofen; mefenamic; nabumetone; tolmetin, and sodium sales ofeach of the foregoing; ketorolac bromethamine; ketorolac tromethamine;ketorolac acid; choline magnesium trisalicylate; rofecoxib; valdecoxib;lumiracoxib; etoricoxib; aspirin; salicylic acid and its sodium salt;salicylate esters of alpha, beta, gamma-tocopherols and tocotrienols(and all their d, 1, and racemic isolers); methyl, ethyl, propyl,isopropyl, n-butyl, sec-butyl, t-butyl, esters of acetylsalicylic acid;tenoxicam; aceclofenac; nimesulide; nepafenac; amfenac; bromfenac;flufenamate; phenylbutazone, or combinations thereof.

Examples of antibiotics include but are not limited toaminoglycosidessuch as streptomycin, amikacin, and tobramycin; macrolines such aserythromycin, clarithromycin, and lincomycin; tetracyclines such astetracycline, dosycycline, chlortetracycline, and minocycline;oxaxolidinones such as linezolid; fusidic acid; and chloramphenicol;beta-lactam penicillins such as penicillin, amoxicillin, dicloxacillin,and ampicillin; beta lactam cephalsporins such as ceftaxime, cefuroxime,cefaclor, and ceftriaxone; beta lacram carbapenems such as impenem andmeropenem; quinolones such as ciprofloxacin, moxifloxacin, andlevofloxacin; sulfonamides such as sulfanilamide and sulfamethoxazole;metronidazole; rifampin; vancomycin; and nitrofurantoin.

Pharmaceutical agents that may be used in the present invention include:(i) pharmacological agents such as, (a) anti-thrombotic agents such asheparin, heparin derivatives, urokinase, and PPack (dextrophenylalanineproline aginine chloromethylketone); antiinflammatory agents such asdexamethasone, prednisolone, corticosterone, budesonide, estrogen,sulfasalazine and mesalamine; (c)antineoplastic/antiproliferative/anti-miotic agents such as paclitaxel,5-fluorouracil, cisplatin, vinblastine, vincristine, epothilones,endostatin, antiostatin, angiopeptin, monoclonal antibodies capable ofblocking smooth muscle cell proliferation, thymidine kinase inhibitors,rapamycin, 40-0-2(Hydroxylethyl) rapamycin (everolimus),40-0-Benzyl-rapamycin, 40-0(4′-Hydroxymethyl)benzyl-rapamycin,40-0-[4′-(1,2-Dihydroxylethyl)]benzyl-rapamycin, 40-Allyl-rapamycin,40-0-[3′-92,2-Dimethyl-1,3-dioxolan-4(S)-yl-prop-2′-en-1′ yl]-20rapamycin, (2′:E,4′S)-40-0-(4′,5′.:Dihydroxypent-2′ en-1′yl), rapamycin40-0(2Hydroxy) ethoxycar-bonylmethyl-rapamycin,40-0-(3-Hydroxypropyl-rapamycin 40-0-((Hydroxyl)hexyl-rapamycin40-0-[2-(2-Hydroxy)ethoxy]ethyl-rapamycin,40-0-[(3S)-(Hydroxy)hexyl-rapamycin40-0-[2-(2-Hydroxy)ethoxy]ethyl-rapamycin,40-0-[(3S)-2,2Dimethyldioxolan-3-yl]methyl-rapamycin,40-0-(2-Nicotinoloxy)ethyl-rapamycin,40-0[2-(N-Methyl-N′-piperazinyl)acetoxy]ethyl-rapamycin,39-0-Desmethyl-3.9,400-0,0 ethylene-rapamycin,(26R)-26-Dihydro-40-0-(2-hydroxy)ethyl-rapamycin, 28-O Methyrapamycin,40-0-(2-Aminoethyl)-rapamycin, 40-0-(2-Acetaminoethyl)-rapamycin40-0(2-Nicotinamidoethyl)-rapamycin,40-0-(3-(N-Methyl-imidazo-2′ylcarbcthoxamido)ethyl)-30 rapamycin,40-0-(2-Ethoxycarbonylaminoethyl)-rapamycin,40-0-(2-Tolylsulfonamidoethyl)-rapamycin,40-0-(2-Ethoxycarbonylaminoethyl)-rapamycin,40-0-(2-Tolylsulfonaminoethyl)-rapamycin,40-0-[2-(4′,5′-Dicarboethoxy-1′,2′,3′-triazol-1′-yl0-ethyl]rapamycin,42-Epi-(telrazolyl) rapamycin (tacrolimus), and42-[3-hydroxy-2-(hydroxymethyl)-3-methylpropanoate] rapamycin(temsirolimus), (d) anesthetic agents such as lidocaine, bupivacaine andropivacaine; € anti-coagulants such as D-Phe-Pro-Arg chloromethylketone, and RGD peptide containing compound, heparin, hirudin,antithrombin compounds, platelet receptor antagonists, antithrombinantibodies, anti-platelet receptor antibodies, aspirin, prostaglandininhibitors, platelet inhibitors and tick antiplatelet peptides; (f)vascular cell growth promoters such as growth factors, transcriptionalactivators, and translational promotors; (g) vascular cell growthinhibitors such as growth factor inhibitors, growth factor receptorantagonists, transcriptional repressors, translational repressors,replication inhibitors, inhibitory antibodies, antibodies directedagainst growth factors, bifunctional molecules consisting of a growthfactor and a cytotoxin, bifunctional molecules consisting of an antibodyand a cytotoxin; (h) protein kinase and tyrosine kinase inhibitors(e.g., tyrophostins, genistein, quinoxalines); (i) prostacyclin analogs;(j) cholesterol-lowering agents; (k) angiopoietins; (l) antimicrobialagents such as triclosan, cephalosporin, aminoglycosides andnitrofurantoin; m) cytotoxic agents, cytostatic agents and cellproliferation affectors; (n) vasodilating agents; and, (o) agents thatinterfere with endogenous vasoactive mechanism, (ii) genetic therapeuticagents include anti-sense DNA and RNA as well as DNA coding for (a)anti-sense RNA, (b) tRNA or rRNA to replace defective or basicfibroblast growth factors, vascular endothelial growth factor, epidermalgrowth factor, transforming growth factor a and P, platelet-derivedendothelial growth factor, platelet-derived growth factor, tumernecrosis factor a, hepatocyte growth factor and insulin-like growthfactor, (d) cell cycle inhibitors including CD inhibitors, and €thymidine kinase (“TK” and other agents useful for interfering with cellproliferation.

Other pharmaceutical agents that can be used, include, acarbosc,antigens, beta-receptor blockers, non-steroidal anti-inflammatory drugs(NSAID, cardiac glycosides, acetylsalicylic acid, virustatics,aclarubicin, acyclovir, cisplatin, actinomycin, alpha- andbeta-sympatomimetrics, (dmeprazole, allopurinol, alprostadil,prostaglandins, amantadine, ambroxol, amlodipine, methotrexate,S-aminosaslicylic acid, amitriptyline, amoxicillin, anastrozole,atenolol, azathioprine, balsalazine, beclomcthasone, betahistine,bezafibrate, bicalutamide, diazepam and diazepam derivatives,budesonide, bufexamac, buprenorphine, methadone, calcium salts,potassium salts, magnesium salts, candesartan, carbamazepine, captopril,cefalosporins, cetirizine, chenodeoxycholic acid, ursodeoxycholic acid,theophylline and theophylline derivatives, trypsins, cimetidine,clarithromycin, clavulanic acid, clindamycin, clobutinol, clonidinc,coytimoxazole, codeine, caffeine, vitamin D and derivatives of vitaminD, colestyramine, cromoglicic acid, coumarin and coumarin derivatives,cysteine, cytarabine, cyclophosamide, cyclosporine, cyproterone,cytabarine, dapiprazole, desogestrel, desonide, dihydralazine,diltiazem, ergot alkaloids, dimenhydrinate, dimethyl sulphoxide,dimeticone, domperidone and domperidan derivatives, doxazosin,doxorubizin, doxylamine, dapiprazole, benzodiazepines, diclofenac,gltcoside antibiotics, desipramine, econazole, ACE inhibitors,enalapril, ephedrine, epinephrine, epoetin and epoetin derivatives,morphinans, calciu antagonists, irinotecan, modafmil, orlistat, peptideantibiotics, phenyltoin, riluzoles, risedronate, sildenafil, topiramatc,macrolide antibiotics, oestrogen and oestrogen derivatives, progestogenand progestogen derivatives, testosterone and testosterone derivatives,androgen and androgen derivatives, ethenzamide, etofenamate, ctofibrate,fenofibrate, etofylHne, etoposide, famciclovir, famotidine, felodipine,fenoftbrate, fentanyl, fenticonazole, gyrase inhibitors, fluconazole,fludarabine, fluarizine, fluorouracil, fluoxetine, flurbiprofen,ibuprofen, flutamide, fluvastatin, follitropin, foromoterol, fosfomicin,furosemide, fusidic acid, gallopamin, ganciclovir, gemfibrozil,gentamicin, ginko, Saint John's wort, glibenclamide, urea derivatives asoral antidiabetics, glucagon, glucosamine and glucosamine derivatives,glutathione, glycerol and glycerol derivatives, hypothalamus hormones,goserelin, gyrase inhibitors, guanethidine, halofantrine, haloperidol,heparin and heparin derivatives, hyaluronic acid, hydralazine,hydrochlorothiazide and hydrochlorothiazide derivatives, salicylates,hydroxyzine, idarubicin, ifosfamide, imipramine, indomethacin,indoramine, insulin, interferons, iodine and iodine derivatives,isoconazole, isoprenaline, glucitol and glucitol derivatives,itraconazole, ketoconazole, ketoprofen, ketotifen, lacidipine,lansoprazole, levodopa, levomethadone, thyroid hormones, lipoic acid andlipoic acid derivatives, Lisinopril, lisuride, lofepramine, lomustine,loperamide, loratadine, maprotiline, mebendazole, mebeverine, meclizine,mefenamic acid, mefloquine, meloxicam, mcpindolol, meprobamate,meropenem, mesalazinc, mesuximide, metamizole, metformin, methotrexate,methylphenidate, methylprednisolone, metixene, metoclopramide,metoprolol, metronidazole, mianserin, miconazole, minocycline,minoxidil, misoprostol, mitomycin, mizolastinc, moexipril, morphine andmorphine derivatives, evening primrose, nalbuphine, naloxone, tilidine,naproxen, narcotine, natamycin, neostigmine, nicergoline, nicethamide,nifedipine, niflumic acid, nimodipine, nimorazole, nimustine,nisoldipine, adrenaline and adrenaline derivatives, norfloxacin,novamine sulfone, noscapine, nystatin, ofloxacin, olanzapine,olsalazine, omeprazole, omoconazole, ondansetron, oxaceprol, oxaqcillin,oxiconazole, oxymetazoline, pantoprazole, paracetamol, paroxetine,penciclovir, oral penicillins, pentazocine, pentifylline,pentoxifylline, perphenazine, pethidine, plant extracts, phenazone,pheniramine, barbituric acid derivatives, phenylbutazone, phenytoin,pimozine, pindolol, piperazine, piracetam, pirenzepine, piribedil,piroxicam, pramipexole, pravastin, prazosin, procaine, promazine,propiverine, propranolol, propyphenazone, prostaglandins, protionamide,proxyphylline, quetiapine, quinapril, quinaprilat, Ramipril, rantidine,reproterol, reserpine, ribavirin, rifampicin, risperidone, ritonavir,ropinirole, roxatidine, roxithromycin, ruscogenin, rutoside and rutosidederivatives, sabadilla, salbutamol, salmeterol, scopolamine, selegiline,sertaconazole, sertindone, sertralion, silicates, sildenafil,simvastatin, sitosterol, sotalol, spaglumic acid, sparfloxacin,spectinomycin, spiramycin, spirapril, spironolactone, stavudine,streptomycin, sucralfate, sufentanil, sulbactam, sulphonamides,sulfasalazine, sulpiridine, sultamicillin, sultiam, sumatriptan,suxamethonium chloride, tacrine, tacrolimus, taliolol, tamoxifen,taurolidine, tazarotene, temazepam, teniposide, tenoxicam, terazosin,terbinafine, terbutaline, terfenadine, terlipressin, tertatolol,tetracyclin, teryzoline, theobromine, theophylline, burizine,thiamazole, phenothiazines, thiotepa, tiagabine, tiapride, propionicacid derivatives, ticlopidine, timolol, tinidazol, tioconazole,tioguanine, tioxolone, tiropramide, tizanidine, tolazolinc, tolbutamide,tolcapone, tolnaftate, tolperisone, topotecan, torasemide,antioestrogens, tramadol, tramazoline, trandolapril, tranylcypromine,trapidil, trazodone, triamcinolone and triamcinolone derivatives,triamterene, trifluperidol, trifluridine, trimethoprim, trimipramine,tripelennamine, triprolidine, trifosfamide, tromantadine, trometamol,tropalpin, troxerutine, tulobutcrol, tyramine, tyrothracin, urapidil,ursodeoxycholic acid, chemodeoxycholic acid, valacirclovir, valproicacid, vancomycin, vecuronium chloride, Viagra, venlafaxine, verapamil,vidarabine, vigabatrine, viloazine, vinblastine, vincamine, vincristine,vindesine, vinorelbine, vinpocetine, viquidil, warfarin, xantinolnicotinate, xipamide, zafirlukast, zalcitabine, zidobudine,zolmitriptan, Zolpidem, zoplicone, zotipine and the like.

While the invention has been particularly shown and described withreference to particular embodiments, it will be appreciated thatvariations of the above-disclosed and other features and functions, oralternatives thereof, may be desirably combined into many otherdifferent systems or applications. Also, various alternatives,modifications, variations or improvements therein may be apparent to andmay subsequently made by those skilled in the art which are alsointended to be encompassed by the following claims.

What is claimed is:
 1. A surgical kit comprising: a bone fixationassembly, wherein the bone fixation assembly is adapted to be fixated ontwo vertebra bones of a subject, and wherein the bone fixation assemblycomprises at least two vertebra joining members each adapted to berespectively secured between two bone anchors; a coupling elementadapted to engage a vertebra joining member at a position between thetwo bone anchors, wherein the coupling element comprises (a) at leasttwo side hooks configured to removably attach to the vertebra joiningmember, and (b) at least two connecting members disposed between the twohooks, the at least two connecting members slidably connected to eachother; and a shield for covering a portion of the spine of the subject,wherein the shield includes an attachment portion adapted to engage thecoupling element, and wherein the shield includes a single bodyconfigured to generally extend in a direction of the spine, the bodyhaving a length suitable for protecting at least a portion of one ormore of the multiple vertebra bones.
 2. The surgical kit of claim 1,each of the two bone anchors comprising a fastener portion adapted to beimplanted into a vertebra bone and a head coupling portion adapted tosecure one of the two vertebra joining members.
 3. The surgical kit ofclaim 1, wherein the shield has a vertical length to cover at least twovertebrae.
 4. The surgical kit of claim 1, wherein the shield comprisesan elongated concavity.
 5. The surgical kit of claim 1, wherein theattachment portion includes two parts extending laterally on oppositesides of the shield.
 6. The surgical kit of claim 1, wherein the shieldis made from a polymeric material.
 7. The surgical kit of claim 1,wherein the shield is made from a material comprising PEEK.
 8. Thesurgical kit of claim 1, wherein the shield further comprises at leastone therapeutic agent selected from the group consisting of ananti-stenotic agent, an anti-fibrotic agent, an anti-inflammatory, anantibiotic agent, and combinations thereof.
 9. The surgical kit of claim8, wherein the at least one therapeutic agent is embedded in abiocompatible matrix.
 10. The surgical kit of claim 9, wherein thematrix further comprises a water-soluble material.
 11. A shield forcovering a portion of the spine of a subject, wherein the shield isfixed to a bone fixation assembly by an attachment portion, wherein theattachment portion is removably attached to a coupling element, whereinthe coupling element is adapted to engage two vertebra joining membersof the bone fixation assembly at a position between two bone anchorsthat the two vertebra joining members are secured between, and whereinthe shield includes a single body configured to generally extend in adirection of the spine, the body having a length suitable for protectingat least a portion of one or more of multiple vertebra bones of thesubject, wherein the coupling element comprises (a) at least two sidehooks configured to removably attach to the vertebra joining member, and(b) at least two connecting members disposed between the two hooks, theat least two connecting members slidably connected to each other,wherein the bone fixation assembly is adapted to be fixated on twovertebra bones of a subject.
 12. The shield of claim 11, wherein thebone fixation assembly comprises a bone screw.
 13. The shield of claim11, wherein the vertebra joining member is a rod.
 14. A shield forcovering a portion of the spine of a subject, comprising: (a) a couplingelement adapted to engage two vertebra joining members of a bonefixation assembly adapted to be fixated on two vertebra bones of thesubject, wherein the bone fixation assembly comprises the two vertebrajoining members that are each adapted to be respectively secured betweentwo bone anchors, wherein the coupling element is adapted to engage thetwo vertebra joining members at a position between the two bone anchors,wherein the coupling element comprises (a) at least two side hooksconfigured to removably attach to the vertebra joining member, and (b)at least two connecting members disposed between the two hooks, the atleast two connecting members slidably connected to each other; and (b) ashield portion for covering a portion of the spine, the shield portionbeing adapted to engage the coupling element, and wherein the shieldportion includes a single body that is configured to generally extend ina direction of the spine, the shield portion having a length suitablefor protecting at least a portion of one or more of the multiplevertebra bones.